High Schools- High on Life: an Intervention to Reduce Excessive Drinking in Danish High Schools

NCT ID: NCT03906500

Last Updated: 2021-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3682 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-08-30

Brief Summary

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High schools High on life' intervention is a high school-based, multi-component intervention guided by theory, evidence, and empirical findings to reduce excessive drinking among Danish high school students. The study will employ a cluster-randomized controlled study design: investigators plan to include a random sample of at least 12 high schools randomly 1:1 allocated to either intervention or control group. Timeline: Baseline data will be obtained from the Danish National Youth Study 2019, collected in January to March 2019. Delivery of intervention: August 2019 to January 2020. Follow-up survey: April to May 2020. Primary outcome measure: mean number of binge-drinking episodes within the last 30 days. Secondary outcome measures: weekly alcohol consumption, alcohol intake at last school party, alcohol intake at the school during last school party, number of students that agrees that they are able to have fun at a party without drinking, and the proportion of students that think alcohol plays a too dominant part at the school. Implementation will be monitored thorough process evaluation.

Detailed Description

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High schools High on life' intervention is a high school-based, multi-component intervention guided by theory, evidence, and empirical findings to reduce excessive drinking among Danish high school students. The study will employ a cluster-randomized controlled study design: based on sample size calculations investigators plan to include a random sample of at least 12 high schools randomly 1:1 allocated to either intervention or control group.

Timeline: Baseline data will be obtained from the Danish National Youth Study 2019, collected in January to March 2019. Delivery of intervention: August 2019 to January 2020. Follow-up survey: April to May 2020. Primary outcome measure: mean number of binge-drinking episodes within the last 30 days. Secondary outcome measures: weekly alcohol consumption, alcohol intake at last school party, alcohol intake at the school during last school party, number of students that agrees that they are able to have fun at a party without drinking, and the proportion of students that think alcohol plays a too dominant part at the school. Implementation will be monitored thorough process evaluation.

Conditions

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Alcohol Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will employ a cluster-randomized controlled study design: investigators plan to include a random sample of at least 12 high schools randomly 1:1 allocated to either intervention or control group.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

The intervention consist of three main components.

School environmental component

The component targeting the high school environment consisted of two separate elements:

* Revision of school alcohol policy
* Appointment of coordinator(s) of student committees organizing events, where alcohol is sold, and student introduction committee.

Student components

The Student components consisted of three main elements:

* Web-based education for the student committees organizing events where alcohol is sold and the student introduction committee
* Pocket movie campaign
* Social norms campaign

Parent components

The parent component consisted of three separate elements:

* Parent Information Meeting
* Parent Information Folder
* Parent Information Website

Group Type EXPERIMENTAL

High schools High on Life

Intervention Type BEHAVIORAL

The intervention consist of three main components.

Environmental factors of the school environment

The component targeting the high school environment consisted of two separate elements:

* Revision of school alcohol policy
* Appointment of coordinator(s) of student committees organizing events, where alcohol is sold, and student introduction committee.

Student component

The Student components consisted of three main elements:

* Online education for the student committees organizing events where alcohol is sold and the student introduction committee
* Pocket movie campaign competition
* Social norms campaign

Parent component

The parent component consisted of three separate elements:

* Parent Information Meeting
* Parent Information Folder
* Parent Information Website

control group

Control high schools was asked to continue business as usual and promised to receive the intervention in the school year starting in 2020

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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High schools High on Life

The intervention consist of three main components.

Environmental factors of the school environment

The component targeting the high school environment consisted of two separate elements:

* Revision of school alcohol policy
* Appointment of coordinator(s) of student committees organizing events, where alcohol is sold, and student introduction committee.

Student component

The Student components consisted of three main elements:

* Online education for the student committees organizing events where alcohol is sold and the student introduction committee
* Pocket movie campaign competition
* Social norms campaign

Parent component

The parent component consisted of three separate elements:

* Parent Information Meeting
* Parent Information Folder
* Parent Information Website

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Enrolled in High school that participate in The Danish National Youth Study 2019
* General High Schools

Exclusion Criteria

* non General High schools students
* non participation in The Danish National Youth Study 2019
Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danish Cancer Society

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Veronica Pisinger

Research assistent

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Veronica Pisinger

Role: PRINCIPAL_INVESTIGATOR

the national institute of public health, Southern Denmark University

Locations

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National Institute of Public Health

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Pisinger VSC, Hoffmann SH, Palsson L, Dalum P, Gronbaek MK, Tolstrup JS, Thygesen LC, Krolner RF. 'High schools High on life': Development of an Intervention to Reduce Excessive Drinking in Danish High Schools. Front Public Health. 2020 Sep 15;8:435. doi: 10.3389/fpubh.2020.00435. eCollection 2020.

Reference Type DERIVED
PMID: 33042935 (View on PubMed)

Pisinger VSC, Hoffmann S, Rosing JA, Gronbaek M, Tolstrup JS, Thygesen L, Krolner R. Study protocol for a cluster randomised controlled trial testing the effectiveness of the 'High schools High on life' intervention on reducing excessive drinking in Danish high schools. BMJ Open. 2020 Aug 6;10(8):e038857. doi: 10.1136/bmjopen-2020-038857.

Reference Type DERIVED
PMID: 32764089 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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15/4155_2

Identifier Type: -

Identifier Source: org_study_id

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